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NCT Number: NCT06859775

SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer

This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Yang Xiang

CONTACT

[email protected]

+86-010-69156086

Yang Xiang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must voluntarily join this study, sign the informed consent form, have good compliance and be able to cooperate with the follow-up.
  • Female, aged 18-75 years old.
  • Expected survival ≥ 12 weeks.
  • Normal function of vital organs.
  • Female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to the first dose and must be non-lactating.
  • Female subjects must agree to comply with contraceptive requirements from signing the informed consent form to 7 months after the last dose of the investigational drug.

Exclusion criteria

  • Previous or concomitant other malignancies.
  • Severe bone damage caused by bone metastasis from tumours.
  • Presence of active autoimmune disease or history of autoimmune disease with possible recurrence.
  • Those with active tuberculosis.
  • Concomitant poorly controlled or severe cardiovascular disease.
  • Occurrence of arteriovenous thrombotic events within 6 months prior to the first dose.
  • Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the first dose.
  • Subjects who have had a serious infection within 1 month before the first dose.
  • Subjects who have a history of immunodeficiency.
  • As judged by the investigator, there are other factors that may affect the results of the study or cause the study to be forced to terminate halfway.

Treatment and study plan

SHR-A1811

Drug

SHR-A1811 injection.

Adebelimab Injection

Drug

Adebelimab injection.

Bevacizumab Injection

Drug

Bevacizumab injection.

SHR-8068

Drug

SHR-8068 injection.

Cisplatin injection

Drug

Cisplatin injection.

Carboplatin injection

Drug

Carboplatin injection.

Primary outcomes

  1. Grade≥3 drug-related adverse events (TRAEs).

    Time frame: Up to 3 years.

  2. Grade≥3 drug-related serious adverse events (TRAEs).

    Time frame: Up to 3 years.

  3. Objective response rate (ORR).

    Time frame: Up to 3 years.

Secondary outcomes

  1. Duration of response (DOR).

    Time frame: Up to 3 years.

  2. Disease control rate (DCR).

    Time frame: Up to 3 years.

  3. Progression-free survival (PFS).

    Time frame: Up to 3 years.

  4. Overall survival (OS).

    Time frame: Up to 3 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 5, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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